Thoracic Paravertebral Block : Effect on Acute Pain and Chronic Pain of Hepatectomy With Right J-shape Subcostal Incision

NCT ID: NCT02817321

Last Updated: 2019-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al. single-injection TPVB +continuous(pulsatile infusion) TPVB and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal incision.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatectomy Analgesia Nerve Block

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single-injection TPVB +continuous TPVB

Single-injection of TPVB is given preoperatively followed with continuous infusion+ postoperative IPCA.

Group Type EXPERIMENTAL

single-injection TPVB + continuous TPVB

Intervention Type PROCEDURE

Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.

Philip CX50 Ultrasound Scanner

Intervention Type DEVICE

The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning

PAJUNK Contiplex S Catheter

Intervention Type DEVICE

single dose ropivacaine

Intervention Type DRUG

* 2mg/kg ropivacaine in saline with 1:200,000 adrenaline, 25ml in total
* given immediately after the correct position of the tip of the needle has been confirmed

continuously infusion of ropivacaine

Intervention Type DRUG

* 0.2% ropivacaine, pulse dosadge: 0.125ml/kg/pulse, 1pulse/h at a rate of 6ml/minutes
* given through the catheter inserted in the T8 paravertebral space following the single dose

Morphine given as IPCA

Intervention Type DRUG

bolus: 2mg, lock time: 10min, 1h limitation: 8mg

IPCA

postoperative IPCA is given alone

Group Type ACTIVE_COMPARATOR

Morphine given as IPCA

Intervention Type DRUG

bolus: 2mg, lock time: 10min, 1h limitation: 8mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

single-injection TPVB + continuous TPVB

Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.

Intervention Type PROCEDURE

Philip CX50 Ultrasound Scanner

The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning

Intervention Type DEVICE

PAJUNK Contiplex S Catheter

Intervention Type DEVICE

single dose ropivacaine

* 2mg/kg ropivacaine in saline with 1:200,000 adrenaline, 25ml in total
* given immediately after the correct position of the tip of the needle has been confirmed

Intervention Type DRUG

continuously infusion of ropivacaine

* 0.2% ropivacaine, pulse dosadge: 0.125ml/kg/pulse, 1pulse/h at a rate of 6ml/minutes
* given through the catheter inserted in the T8 paravertebral space following the single dose

Intervention Type DRUG

Morphine given as IPCA

bolus: 2mg, lock time: 10min, 1h limitation: 8mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo hepatectomy with J-shape subcostal incision
* Informed consent

Exclusion Criteria

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cui Xulei

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cui Xulei

Attending physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yuguang Huang, MD.

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xulei CUI

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

cuixulei2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.